OVERVIEWThe Trial Supplies Operations Manager is responsible for the implementation of appropriate Clinical Supplies strategies and processes in order to achieve clinical study objectives in assigned programs. Responsibilities Include: Receives the Extended Synopsis/protocol and will provide feedback /comments to Project leaders and Clinical teamsObtain detail information about Clinical trials assigned including IP design, countries, blinded or open label trials, distribution strategy and other details.Work in collaboration with other functional team to identify forecasting strategy, IP/Ancillaries/comparators and other requirements for the assigned trials.Monitoring patient recruitment and adjust the resupply strategy as needed.Work in collaboration with internal and external stakeholders to plan the labeling requirements, packaging plan and domestic and international distribution.Initiates label request for clinical supplies meeting regulatory requirements for each market.Monitor the distribution plan including the IVR activities, making sure that IP are delivered in good condition for patients al all the time.Responsible for the Pre-Audit preparation for assigned trials, making sure that all documentation is correct and available for internal and external auditors.Interaction with local country representatives (IPM) and depots to coordinate over-labeling and/or rework operations.Constant interaction with quality (SQO), making sure that all activities related with assigned studies are within compliance. Skills: Strong verbal and written communication skills are required.Demonstrated ability to work effectively in a global matrix team environmentAble to manage multiple projects and interact with different functional groupsWork under pressure and tight timeliness Education: Bachelors Degree (Science) requiredA degree in Pharmacy (Pharm. D) or Master degree preferred.3 – 5 years of hospital pharmacy or equivalent pharmaceutical/biotech industry experience. Project Manager experience.
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